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New treatment option for Chemotherapy-inducing Anemia
Official title Luspatercept for CIA in AML
ClinicalTrials.gov ID: NCT07663864
What this study is testing
What is Luspatercept Injectable Product?
Luspatercept Injectable Product is an investigational medicine, being studied as a potential treatment for chemotherapy-inducing anemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to explore the feasibility, safety, and preliminary efficacy of rotegcipipone in the treatment of chemotherapy-inducing anemia in AML with a multicenter, prospective, single-arm trial, providing clinical evidence for subsequent clinical development.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- De novo AML patients;
- Age ≥ 18 years and ≤ 60 years;
- AML with ELN2022-low risk
- Received 1-3 cycles of HDAC consolidation therapy
- HGB 60-90 G/L
You likely can't join if
- t-AML/sAML
- Concurrent myelofibrosis
- Patients unresponsive to red blood cell transfusions
- Heart function \< grade 2
- Renal function: creatinine clearance \< 30 ml/min
- Liver function: ALTd \> 5 times normal, bilirubin \> 3 times normal
See the full eligibility criteria
- De novo AML patients;
- Age ≥ 18 years and ≤ 60 years;
- AML with ELN2022-low risk
- Received 1-3 cycles of HDAC consolidation therapy
- HGB 60-90 G/L
- Eastern Cooperative Oncology Group (ECOG) score ≤ 2 points;
- Life expectancy ≥ 3 months;
- Signed informed consent and able to understand and comply with the procedures required by this protocol.
- t-AML/sAML
- Concurrent myelofibrosis
- Patients unresponsive to red blood cell transfusions
- Heart function \< grade 2
- Renal function: creatinine clearance \< 30 ml/min
- Liver function: ALTd \> 5 times normal, bilirubin \> 3 times normal
- Uncontrolled hypertension, defined as recurrent elevations in diastolic blood pressure (DBP) ≥ 100 mmHg despite adequate treatment
- History of stroke, deep vein thrombosis (DVT), pulmonary or arterial embolism within 6 months prior to randomization
- Uncontrolled systemic fungal, bacterial, or viral infection (defined as persistent infection-related signs/symptoms that do not improve despite appropriate antibiotic, antiviral, and/or other treatments), known human...
- History of severe allergy or allergic reaction to recombinant proteins, or allergy to rotezip or excipients
- Pregnant or breastfeeding women
- Patients deemed unsuitable for enrollment by the investigators
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.